Social Media and Risk-reduction Training for Preterm Infant Care Practices

Обзор

SMART Preemie is a cluster randomized trial that will investigate the effectiveness of NICU-based and post-discharge interventions to improve adherence to safe sleep practices among mothers of preterm infants. This study includes two complementary, culturally competent, intervention strategies and will test the effectiveness of each strategy, as well as both strategies in combination. The attention matched-control intervention will focus on shared reading. The SMART Preemie study will have four arms in which 16 hospitals are randomly assigned to one of the following study groups: 1) Safe Sleep NICU Quality Improvement Campaign and Shared Reading TodaysNICUBaby videos and messages; 2) Shared Reading NICU Quality Improvement Campaign and Safe Sleep TodaysNICUBaby videos and messages; 3) Safe Sleep NICU Quality Improvement Campaign and Safe Sleep TodaysNICUBaby videos and messages; 4) Shared Reading NICU Quality Improvement Campaign and Shared Reading TodaysNICUBaby videos and messages. A total of 1600 mothers will be recruited (100/hospital), with 400 in each study group. The primary aim is to assess the effectiveness of the interventions aimed at promoting safe sleep practices compared with the shared reading control interventions. The secondary aim is to assess potential mediating factors that may explain the intervention effects on infant care practices and that may inform areas for future improved intervention approaches. The tertiary aim is to assess key implementation outcomes which will be used for future scale-up. With the successful completion of the SMART Preemie study, effectiveness, mechanism, and implementation data will have been provided for two interventions to improve adherence to safe sleep practices that are practical to disseminate nationally in multiple diverse settings.

Вмешательства

• Поведенческое Safe Sleep NICU Quality Improvement Campaign
  We will train NICU staff working in hospitals randomized to the safe sleep intervention to: (1) Model safe sleep practices when infants achieve medical stability according to AAP guidelines ; and (2) Provide education to parents about safe sleep throughout the NICU hospitalization, as it relates to their infants reaching medical stability and readiness to be placed in supine positions in a sleep area without any unsafe objects in the NICU and in the home environment.
• Поведенческое Shared Reading NICU Quality Improvement Campaign
  We will train NICU staff working in hospitals randomized to the shared reading intervention to: 1. Model shared reading practices with book distribution, and 2. Provide education to parents about shared reading. Hospital staff may use any materials from our toolkits as needed and we ask for staff to provide education to parents, and model shared reading, when distributing a new book to the family within the first week of admission, and then every 2 weeks while their child is in the NICU.
• Поведенческое Safe Sleep TodaysNICUBaby videos and messages
  The TodaysNICUBaby mHealth program is comprised of: 1. text message-delivered, short educational videos in the first 8 weeks after NICU discharge and 2. text queries regarding safe sleep or shared reading practices, which collect data on these practices in near real-time and provide reinforcement of adherence.
• Поведенческое Shared Reading TodaysNICUBaby videos and messages
  The Shared Reading TodaysNICUBaby mHealth program is comprised of: 1. text message-delivered, short educational videos in the first 8 weeks after NICU discharge and 2. text queries regarding shared reading, which collect data on these practices in near real-time and provide reinforcement of adherence.

Первичные конечные точки

• Impact of the NICU safe sleep intervention on safe infant sleep position [Срок оценки: 60 days post-discharge]
• Impact of the NICU safe sleep intervention on safe infant sleep location [Срок оценки: 60 days post-discharge]
• Impact of the NICU safe sleep intervention safe sleep space [Срок оценки: 60 days post-discharge]
• Impact of the NICU safe sleep intervention on safe infant sleep environment [Срок оценки: 60 days post-discharge]
• Impact of the mHealth post-discharge safe sleep intervention on safe infant sleep position [Срок оценки: 60 days post-discharge]
• Impact of the mHealth post-discharge safe sleep intervention on safe infant sleep location [Срок оценки: 60 days post-discharge]
• Impact of the mHealth post-discharge safe sleep intervention safe sleep space [Срок оценки: 60 days post-discharge]
• Impact of the mHealth post-discharge safe sleep intervention on safe infant sleep environment [Срок оценки: 60 days post-discharge]
• Impact of the NICU and mHealth post-discharge safe sleep intervention on safe infant sleep position [Срок оценки: 60 days post-discharge]
• Impact of the NICU and mHealth post-discharge safe sleep intervention on safe infant sleep location [Срок оценки: 60 days post-discharge]

Вторичные конечные точки (12)

• Safe infant sleep position by maternal race/ethnicity [Срок оценки: 60 days post-discharge]
• Safe infant sleep location by maternal race/ethnicit [Срок оценки: 60 days post-discharge]
• Safe sleep space by maternal race/ethnicity [Срок оценки: 60 days post-discharge]
• Safe infant sleep environment by maternal race/ethnicity [Срок оценки: 60 days post-discharge]
• Safe infant sleep position by infant gestational age [Срок оценки: 60 days post-discharge]
• Safe infant sleep location by infant gestational age [Срок оценки: 60 days post-discharge]
• Safe sleep space by infant gestational age [Срок оценки: 60 days post-discharge]
• Safe infant sleep environment by infant gestational age [Срок оценки: 60 days post-discharge]
• Impact of the NICU safe sleep intervention on intention for safe infant sleep position [Срок оценки: Baseline and 60 days post-discharge]
• Impact of the NICU safe sleep intervention on intention for safe infant sleep location [Срок оценки: Baseline and 60 days post-discharge]
• Impact of the NICU safe sleep intervention on intention for safe infant safe sleep space [Срок оценки: Baseline and 60 days post-discharge]
• Impact of the NICU safe sleep intervention on intention for safe infant sleep environment [Срок оценки: Baseline and 60 days post-discharge]

Критерии участия

Критерии включения

• English- or Spanish- speaking mothers of preterm infants (gestational age <37 weeks' weeks)
• Infant must have been admitted to one of the 16 participating NICUs for at least 7 days
• Infant must be discharged home from one of the 16 participating NICUs within 56 weeks post-menstrual age (>95% of preterm infants)
• Infant must be discharged to the care of the mother (not a foster family) who intends to care for the child in the US for the first 6 months post-discharge
• Must have a phone that can receive text messages and view videos

Критерии исключения

• Known or reported mental health or other issues that would preclude custody of the infant or being able to participate in the informed consent process.
• Infant has contraindications to safe sleep positioning (e.g. extremely rare conditions of the airway or lower spine)
• Meets the definition of a minor according to applicable state law.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Факторный дизайн

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

США · 1 центр

• University of Massachusetts Chan Medical School — Worcester

Идентификаторы

NCT: NCT07420686 · STUDY00002732 · 2R01HD095060-06

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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